Validation of Home Blood Glucose Meters With Respect to Clinical and Analytical Approaches

In Validation of Home Blood Glucose Meters With Respect to Clinical and Analytical Approaches, published in the April 1998 edition of Diabetes Care, researchers report that the "analytical performance of currently available home blood glucose meters differs substantially within defined glycemic ranges." Using an error grid analysis, with readings separated into three glycemic ranges, researchers found that none of the tested meters met ADA criteria for analytical error of less than 5%.

The three glycemic ranges tested were:

Low (< 3.89 mmol [70 mg/dl])

Near-normal (3.89-9.99 mmol [70-180 mg/dl])

High (> 9.99 mmol [180 mg/dl])

Here is a summary of the results for the six meters tested:

Refloflux S (Boehringer Mannheim, Germany)
100% of measurements were Clinically Accurate for Low and High ranges. 83.1% of results were Clinically Accurate for Near-Normal, with the remaining 16.9% showing Benign Estimate Errors.

One Touch II (LifeScan, USA)
96.6% of measurements were Clinically Accurate for the Low range, while 3.4% were Dangerous Failure to Detect and Treat [incorrectly reported high or low]. 100% of results were Clinically Accurate for Near-Normal and High.

Glucocard Memory (Menarini, Italy)
100% of measurements were Clinically Accurate for the Low range. 94.3% of results were Clinically Accurate for Near-Normal, with the remaining 5.7% showing Benign Estimate Errors. 78% of results were Clinically Accurate for High, with the remaining 22% showing Benign Estimate Errors.

Precision QID (Medisence, USA)
79.7% of measurements were Clinically Accurate for the Low range, while 20.3% were Dangerous Failure to Detect and Treat [incorrectly reported high or low]. 82.9% of results were Clinically Accurate for Near-Normal, with the remaining 17.1% showing Benign Estimate Errors. 97.5% of results were Clinically Accurate for High, with the remaining 2.5% showing Benign Estimate Errors.

HaemoCue (HaemoCue, Sweden)
99.1% of measurements were Clinically Accurate for the Low range, while 0.9% were Dangerous Failure to Detect and Treat [incorrectly reported high or low]. 98.6% of results were Clinically Accurate for Near-Normal, with the remaining 1.4% showing Benign Estimate Errors. 93.3% of results were Clinically Accurate for High, with 4.5% showing Benign Estimate Errors and 2.2% showing Dangerous Failure to Detect and Treat [incorrectly reported high or low].

Accutrend Alpha (Boehringer Mannheim, Germany)
97.5% of measurements were Clinically Accurate for the Low range, while 2.5% were Dangerous Failure to Detect and Treat [incorrectly reported high or low]. 98.6% of results were Clinically Accurate for Near-Normal, with the remaining 1.4% showing Benign Estimate Errors. 100% of results were Clinically Accurate for High.

Commentary by Dr. William Quick, Medical Director of Children with Diabetes:

Although this study points out that recent models of meters still aren't as
good as they might be, it should not be assumed that the information
in this study means that we shouldn't be doing sugar testing with these
meters!

At a meeting I recently attended (of the American Association of Clinical
Endocrinologists, May 1998), two experts discussed the use of intravenous
insulin in hospital settings; they both stated, in response to a question
from the audience, that they exclusively use such meters in the hospital to
adjust insulin doses for their critically ill patients, unless the sugar
level were so high that it doesn't register on the meter. They both clearly
indicated that they had no reservations about the meters giving misleading
information that would interfere with the insulin therapy. And I think most
diabetes doctors and diabetes educators will agree with the experts I
listened to, and not with the authors of this article: we know the meters
aren't perfect, but the meters are okay to use for monitoring diabetes and
for adjusting therapy in people with diabetes.

Posted 3 May 1998

Last Updated: Thursday February 27, 2014 19:28:21
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